The News & Observer (Raleigh
---- — RALEIGH, N.C. — People for the first time will have the option of getting inoculated against the flu with a newly developed 4-strain vaccine rather than the 3-strain vaccine that’s been in use for decades.
The U.S. Food and Drug Administration approved a shot for four flu strains Thursday — after approving a similar vaccine in December — as preventives against the virus that kills thousands of Americans each year. Both vaccines were developed by pharmaceutical giant GlaxoSmithKline after public health officials repeatedly wrongly predicted which flu strains would be the most dominant. GSK plans to deliver about 10 million doses for the upcoming flu season, along with at least 12 million doses of the traditional flu vaccine made for three strains.
The two GSK vaccines — Flulaval Quadrivalent and Fluarix Quadrivalent — are approved for children as young as 3 years old.
“This is the first influenza season coming up where quadrivalent vaccine will be available,” said Leonard Friedland, GSK’s director for scientific affairs and public health. “We expect in the next few years the market will switch to quadrivalent formulations.”
GSK, which employs 4,600 people in the Triangle area of North Carolina, will be the dominant supplier of the new vaccine, at least in the first year. Two other makers of 4-strain flu vaccine will either produce a limited supply or a vaccine in inhaler form.
Friedland said the new vaccines will provide broader coverage against influenza viruses that health experts project to be the most prevalent, but will not provide total immunity against influenza. GSK’s new vaccines are made in Germany and in Canada.
“There will be broader protection,” Friedland said.
Each year the World Health Organization recommends to public health agencies which flu vaccine formulations to stockpile. The recommendation is based on the organization’s prediction of which flu strains will be active that year.
But the WHO has wrongly predicted which strain would be dominant six times in the past 11 years, GSK officials said, which resulted in formulations that did not provide the fullest protection to the public.
Vaccines with four strains are designed to increase the odds that the inoculation will be effective and not rely as much on the guesswork of scientists.
In some cases a new virus emerges for which there is no vaccine. The last time that happened was in 2009, with the emergence of the H1N1 flu virus. Seasonal vaccines now inoculate against the H1N1 strain.
The U.S. Centers for Disease Control and Prevention, in a 2012 study, said the benefits of 4-strain vaccines will depend on the number of people who are inoculated and on the virus strains in circulation. The agency said the benefits will likely be “modest” but noted that the use of 4-strain vaccines could prevent as many as 970,000 flu cases and up to 485 deaths in this country.
The vaccines are being shipped to doctors, health centers, businesses, health agencies, pharmacies, retailers and others that have placed orders.
The wholesale price for GSK’s 4-strain vaccines is about one-third higher than the cost of the traditional vaccine for three strains, said GSK spokesman Rob Perry.
GSK’s wholesale price to health care providers is $15.50 a dose for Fluarix Quadrivalent, which is delivered in prefilled syringes, and $14.15 for a dose of Flulaval Quadrivalent, which comes in vials. Perry said that the price can vary by the size of the order.